Multiple bioabsorbable corticosteroid‐eluting stent placement with associated skull base injury

Tang, Dennis M.; Roxbury, Christopher R.; Sindwani, Raj; Kshettry, Varun R.; Recinos, Pablo F.; Woodard, Troy D.

doi:10.1002/lary.27659

Cited by 6 publications

(4 citation statements)

References 9 publications

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“…15 Additionally, there has been 1 reported case of skull base injury after deployment of multiple BCES. 16 In light of sparse reporting of complications, our study highlights potential complications of which physicians should be aware when treating patients with PROPEL BCES and suggests future considerations for evaluating risk factors for complications following placement of drug-eluting stents in sinus surgery.…”

Section: Discussionmentioning

confidence: 93%

Complications Associated with PROPEL Mometasone Furoate Bioabsorbable Drug-eluting Sinus Stents From 2012 to 2020

Shah

Pasick

Benito

et al. 2021

Am J Rhinol�Allergy

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Background Till date, there have been no studies that have analyzed a database to examine postmarket adverse events associated with PROPEL mometasone furoate bioabsorbable drug-eluting sinus stents. Objective To determine the postmarket complications associated with PROPEL mometasone furoate bioabsorbable drug-eluting sinus stents. Methods The US Food and Drug Administration’s Manufacturer and User Facility Device Experience database was searched for adverse events associated with PROPEL bioabsorbable drug-eluting sinus stents between January 1, 2012 and December 31, 2020. Data were extracted and analyzed from medical device reports (MDRs) that involved sinus stents. Results After 47 MDRs were identified, 25 reports involving PROPEL bioabsorbable drug-eluting sinus stents were reviewed, from which 40 adverse events were recorded. Of these, there were 32 adverse events to patients and 8 device malfunctions. The most common adverse events to patients included infection (21.8%), oropharyngeal obstruction (15.6%), and headache/pain (12.5%). The most common device malfunction reported was migration and expulsion of the stent (87.5%). Conclusions PROPEL sinus stents have been shown to be effective in preventing sinus outflow obstruction after functional endoscopic sinus surgery. Both adverse events to patients and device malfunctions are reported infrequently. A more comprehensive understanding of rare postmarket complications seen with PROPEL sinus stents may further aid informed decision-making regarding their usage.

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Section: Discussionmentioning

confidence: 93%

Complications Associated with PROPEL Mometasone Furoate Bioabsorbable Drug-eluting Sinus Stents From 2012 to 2020

Shah

Pasick

Benito

et al. 2021

Am J Rhinol�Allergy

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“…Conversely, a smaller single institution randomized controlled trial compared SES to Merocel and found no long-term statistical difference in MT lateralization, LKES, or Sino-nasal Outcome Test (SNOT-22) score [35]. Although judicious use of SES has been shown to be safe and effective, there is a report of skull base injury in the setting of improper placement of a SES [36], emphasizing that these new technologies are not a substitute for comprehensive understanding of surgical anatomy and meticulous operative technique.…”

Section: Middle Turbinate Medialization Techniquesmentioning

confidence: 99%

Management of the middle turbinate during and after sinus surgery

Tang

Roxbury

2021

Current Opinion in Otolaryngology &Amp; Head &Amp; Neck Surgery

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Purpose of reviewTreatment of the middle turbinate (MT) during and after endoscopic sinus surgery (ESS) has been controversial. Historically, there has been concern that resection of the MT may result in smell loss and frontal sinus stenosis. However, these concerns must be balanced by knowledge that a residual diseased MT may result in surgical failure. This review discusses the current evidence on treatment of the MT during and after ESS. Recent findingsSeveral review articles have shown the safety of performing MT resection. Studies have not shown increase rates of frontal sinus stenosis, olfactory loss, or empty nose syndrome. However, the benefit of MT resection is highly debated. There have also been many recent advances and technological developments to assist in management of the postoperative MT.

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“…This inflammatory response can lead to clinical adverse events including crusting, granulation, and scarring [9] as well as nasal and ocular irritation [10]. In one severe case, a stent was found to be extending through the skull base into the brain with significant cognitive consequences [11]. In this instance, the patient had undergone extensive surgery and 8 stents were placed throughout the sinus cavities [11].…”

Section: Introductionmentioning

confidence: 99%

“…In one severe case, a stent was found to be extending through the skull base into the brain with significant cognitive consequences [11]. In this instance, the patient had undergone extensive surgery and 8 stents were placed throughout the sinus cavities [11]. The varying anatomy of the four sinuses (ethmoid, maxillary, frontal, and sphenoid) necessitates individual stents for each cavity and incorrect placement can lead to complications.…”

Section: Introductionmentioning

confidence: 99%

A thermoresponsive hydrogel system for long-acting corticosteroid delivery into the paranasal sinuses

Schilling

Külahçi

Moore

et al. 2021

Journal of Controlled Release

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Delivering localized treatment to the paranasal sinuses for diseases such as chronic rhinosinusitis (CRS) is particularly challenging because of the small natural openings leading from the sinuses that can be further obstructed by presence of inflammation. As such, oral steroids, topical nasal sprays or irrigation, and surgery can be utilized to treat persistent sinonasal inflammation, but there exists a need for post-operative options for long-term steroid delivery to prevent disease recurrence. In the present study, a Thermogel, Extended-release Microsphere-based-delivery to the Paranasal Sinuses (TEMPS) is developed with the corticosteroid mometasone furoate. Specifically, the bioactive steroid is released for 4 weeks from poly(lactic-co-glycolic acid) (PLGA) microspheres embedded in a poly(N-isopropylacrylamide) (p-NIPAAm)-based hydrogel. The temperature-responsive system undergoes a reversible sol-gel transition at 34-35 °C such that it can be applied as a liquid at ambient temperature, conforming to the sinonasal epithelium as it gels. In a rabbit model of CRS, TEMPS was maintained in rabbit sinuses and effectively reduced sinonasal inflammation as characterized by micro-computed tomography and histopathology *

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Multiple bioabsorbable corticosteroid‐eluting stent placement with associated skull base injury

Cited by 6 publications

References 9 publications

Complications Associated with PROPEL Mometasone Furoate Bioabsorbable Drug-eluting Sinus Stents From 2012 to 2020

Complications Associated with PROPEL Mometasone Furoate Bioabsorbable Drug-eluting Sinus Stents From 2012 to 2020

Management of the middle turbinate during and after sinus surgery

A thermoresponsive hydrogel system for long-acting corticosteroid delivery into the paranasal sinuses

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